Making Science Computable Using Evidence-Based Medicine on Fast Healthcare Interoperability Resources: Standards Development Project.

BACKGROUND: Evidence-based medicine (EBM) has the potential to improve health outcomes, but EBM has not been widely integrated into the systems used for research or clinical decision-making. There has not been a scalable and reusable computer-readable standard for distributing research results and synthesized evidence among creators, implementers, and the ultimate users of that evidence. Evidence that is more rapidly updated, synthesized, disseminated, and implemented would improve both the delivery of EBM and evidence-based health care policy. OBJECTIVE: This study aimed to introduce the EBM on Fast Healthcare Interoperability Resources (FHIR) project (EBMonFHIR), which is extending the methods and infrastructure of Health Level Seven (HL7) FHIR to provide an interoperability standard for the electronic exchange of health-related scientific knowledge. METHODS: As an ongoing process, the project creates and refines FHIR resources to represent evidence from clinical studies and syntheses of those studies and develops tools to assist with the creation and visualization of FHIR resources. RESULTS: The EBMonFHIR project created FHIR resources (ie, ArtifactAssessment, Citation, Evidence, EvidenceReport, and EvidenceVariable) for representing evidence. The COVID-19 Knowledge Accelerator (COKA) project, now Health Evidence Knowledge Accelerator (HEvKA), took this work further and created FHIR resources that express EvidenceReport, Citation, and ArtifactAssessment concepts. The group is (1) continually refining FHIR resources to support the representation of EBM; (2) developing controlled terminology related to EBM (ie, study design, statistic type, statistical model, and risk of bias); and (3) developing tools to facilitate the visualization and data entry of EBM information into FHIR resources, including human-readable interfaces and JSON viewers. CONCLUSIONS: EBMonFHIR resources in conjunction with other FHIR resources can support relaying EBM components in a manner that is interoperable and consumable by downstream tools and health information technology systems to support the users of evidence.

Electronic Health Record-Based Recruitment and Retention and Mobile Health App Usage: Multisite Cohort Study.

BACKGROUND: To address the obesity epidemic, there is a need for novel paradigms, including those that address the timing of eating and sleep in relation to circadian rhythms. Electronic health records (EHRs) are an efficient way to identify potentially eligible participants for health research studies. Mobile health (mHealth) apps offer available and convenient data collection of health behaviors, such as timing of eating and sleep. OBJECTIVE: The aim of this descriptive analysis was to report on recruitment, retention, and app use from a 6-month cohort study using a mobile app called Daily24. METHODS: Using an EHR query, adult patients from three health care systems in the PaTH clinical research network were identified as potentially eligible, invited electronically to participate, and instructed to download and use the Daily24 mobile app, which focuses on eating and sleep timing. Online surveys were completed at baseline and 4 months. We described app use and identified predictors of app use, defined as 1 or more days of use, versus nonuse and usage categories (ie, immediate, consistent, and sustained) using multivariate regression analyses. RESULTS: Of 70,661 patients who were sent research invitations, 1021 (1.44%) completed electronic consent forms and online baseline surveys; 4 withdrew, leaving a total of 1017 participants in the analytic sample. A total of 53.79% (n=547) of the participants were app users and, of those, 75.3% (n=412), 50.1% (n=274), and 25.4% (n=139) were immediate, consistent, and sustained users, respectively. Median app use was 28 (IQR 7-75) days over 6 months. Younger age, White race, higher educational level, higher income, having no children younger than 18 years, and having used 1 to 5 health apps significantly predicted app use (vs nonuse) in adjusted models. Older age and lower BMI predicted early, consistent, and sustained use. About half (532/1017, 52.31%) of the participants completed the 4-month online surveys. A total of 33.5% (183/547), 29.3% (157/536), and 27.1% (143/527) of app users were still using the app for at least 2 days per month during months 4, 5, and 6 of the study, respectively. CONCLUSIONS: EHR recruitment offers an efficient (ie, high reach, low touch, and minimal participant burden) approach to recruiting participants from health care settings into mHealth research. Efforts to recruit and retain less engaged subgroups are needed to collect more generalizable data. Additionally, future app iterations should include more evidence-based features to increase participant use.

Understanding Primary Care Patients' Self-weighing Habits: Cohort Analysis from the PaTH Clinical Data Research Network.

BACKGROUND: Greater than 60% of adults have overweight or obesity. Self-weighing is an effective weight loss and weight maintenance tool. However, little is known about self-weighing habits among the primary care patient population. Our objective was to examine the frequency of patient-reported self-weighing, and to evaluate the associations of self-weighing with demographic characteristics and self-monitoring behaviors. METHODS: We conducted an analysis of survey data collected as part of the PaTH Clinical Data Research Network, which recruited a cohort of 1,021 primary care patients at 4 academic medical centers. Patients of all body mass index (BMI) categories were included. RESULTS: Response rate of 6-month survey was 727 (71%). The mean age was 56 years, and most were female (68%), White (78%), college graduates (66%), and employed/retired (85%). The mean BMI was 30.2 kg/m2, 80% of participants had a BMI â‰§ 25 kg/m2. Of patients with BMI â‰§ 25 kg/m2, 35% of participants self-weighed weekly and 23% daily. Participants who reported self-weighing at least weekly were more likely to be older (59 vs 54 years, p < 0.01), married (p = 0.01), college graduates (p = 0.03), White (p < 0.01), and employed vs disabled/unemployed (p < 0.01). Patients who self-weighed daily had a lower BMI (29 kg/m2 vs 31 kg/m2, p = 0.04). Patients who tracked exercise or food intake were more likely to self-weigh daily (p < 0.01), as were patients wanting to lose or maintain weight (p < 0.01). CONCLUSIONS: Despite its potential for primary and secondary obesity prevention, only 35% of primary care patients with overweight or obesity engage in self-weighing weekly and less than a quarter (23%) self-weigh daily. Socioeconomic status appears to be a factor influencing regular self-weighing in this population, potentially contributing to greater health disparities in obesity rates. Patients who self-weighed daily had a lower BMI, suggesting that it may play a role in primary prevention of obesity. More work is needed to explore self-weighing among patients.

Developing a risk-based composite neurologic outcome for a trial of hydroxyurea in young children with sickle cell disease.

BACKGROUND: Studies of interventions to prevent the many neurological complications of sickle cell disease must take into account multiple outcomes of variable severity, with limited sample size. The goals of the studies presented were to use investigator preferences across outcomes to determine an attitude-based weighting of relevant clinical outcomes and to establish a valid composite outcome for a clinical trial. METHODS: In Study 1, investigators were surveyed about their practice regarding hydroxyurea therapy and opinions about outcomes for the "Hydroxyurea to Prevent the Central Nervous System Complications of Sickle Cell Disease Trial" (HU Prevent), and their minimally acceptable relative risk reduction for the two outcome components, motor and neurocognitive deficits. In Study 2, HU Prevent investigators provided overall weights for these two components. In Study 3, they provided more granular rankings, ratings, and maximum number acceptable to harm. A weighted composite outcome, the Stroke Consequences Risk Score, was constructed that incorporates the major neurologic complications of sickle cell disease. The Stroke Consequences Risk Score represents the 3-year risk of suffering the adverse consequences of stroke. In Study 4, the results of the Optimizing Primary Stroke Prevention in Sickle Cell Anemia (STOP2) and Silent Infarct Transfusion Trials were reanalyzed in light of the composite outcome. RESULTS: In total, 22 to 27 investigators participated per study. In Study 1, across three samplings between 2009 and 2015, the average minimally acceptable relative risk reduction ranged from 0.36 to 0.50, at or below the target effect size of 0.50. In 2015, 21 (91%) reported that a placebo-controlled trial is reasonable; 23 (100%), that it is ethical; and 22 (96%), that they would change their practice, if the results of the trial were positive. In Studies 2 and 3, the weight elicited for a cognitive decline (of 10 IQ points) from the overall assessment was 0.67 (and for motor deficit, the complementary 0.33); from ranking, 0.6; from rating, 0.58; and from maximal number acceptable to harm, 0.5. Using data from two major clinical trials, Study 4 demonstrated the same conclusions as the original trials using the Stroke Consequences Risk Score, with smaller p-values for both reanalyses. An assessment of acceptability was performed as well. CONCLUSION: This set of studies provides the rationale, justification, and validation for the use of a weighted composite outcome and confirms the need for the phase III HU Prevent study. Surveys of investigators in multi-center studies can provide the basis of clinically meaningful outcomes that foster the translation of study results into practice while increasing the efficiency of a study.

Preemptive Bone Marrow Transplantation for FANCD1/BRCA2.

Children with biallelic mutations in FANCD1/BRCA2 are at uniquely high risks of leukemia and solid tumors. Preemptive bone marrow transplantation (PE-BMT) has been proposed to avoid the development of leukemia, but empirical study of PE-BMT is unlikely because of the rarity of these children and the unknown benefit of PE-BMT. We used survival analysis to estimate the risks of leukemia and the expected survival if leukemia could be eliminated by curative PE-BMT. We used the results in a decision analysis model to explore the plausibility of PE-BMT for children with variable ages at diagnosis and risks of transplantation-related mortality. For example, PE-BMT at 1 year of age with a 10% risk of transplantation-related mortality increased the mean survival by 1.7 years. The greatest benefit was for patients diagnosed between 1 and 3 years of age, after which the benefit of PE-BMT decreased with age at diagnosis, and the risk of death from solid tumors constituted a relatively greater burden of mortality. Our methods may be used to model survival for other hematologic disorders with limited empirical data and a pressing need for clinical guidance.

The Ontology of Clinical Research (OCRe): an informatics foundation for the science of clinical research.

To date, the scientific process for generating, interpreting, and applying knowledge has received less informatics attention than operational processes for conducting clinical studies. The activities of these scientific processes - the science of clinical research - are centered on the study protocol, which is the abstract representation of the scientific design of a clinical study. The Ontology of Clinical Research (OCRe) is an OWL 2 model of the entities and relationships of study design protocols for the purpose of computationally supporting the design and analysis of human studies. OCRe's modeling is independent of any specific study design or clinical domain. It includes a study design typology and a specialized module called ERGO Annotation for capturing the meaning of eligibility criteria. In this paper, we describe the key informatics use cases of each phase of a study's scientific lifecycle, present OCRe and the principles behind its modeling, and describe applications of OCRe and associated technologies to a range of clinical research use cases. OCRe captures the central semantics that underlies the scientific processes of clinical research and can serve as an informatics foundation for supporting the entire range of knowledge activities that constitute the science of clinical research.

Autonomous artificial intelligence increases screening and follow-up for diabetic retinopathy in youth: the ACCESS randomized control trial.

Diabetic retinopathy can be prevented with screening and early detection. We hypothesized that autonomous artificial intelligence (AI) diabetic eye exams at the point-of-care would increase diabetic eye exam completion rates in a racially and ethnically diverse youth population. AI for Children's diabetiC Eye ExamS (NCT05131451) is a parallel randomized controlled trial that randomized youth (ages 8-21 years) with type 1 and type 2 diabetes to intervention (autonomous artificial intelligence diabetic eye exam at the point of care), or control (scripted eye care provider referral and education) in an academic pediatric diabetes center. The primary outcome was diabetic eye exam completion rate within 6 months. The secondary outcome was the proportion of participants who completed follow-through with an eye care provider if deemed appropriate. Diabetic eye exam completion rate was significantly higher (100%, 95%CI: 95.5%, 100%) in the intervention group (n = 81) than the control group (n = 83) (22%, 95%CI: 14.2%, 32.4%)(p < 0.001). In the intervention arm, 25/81 participants had an abnormal result, of whom 64% (16/25) completed follow-through with an eye care provider, compared to 22% in the control arm (p < 0.001). Autonomous AI increases diabetic eye exam completion rates in youth with diabetes.

Caveats for the use of operational electronic health record data in comparative effectiveness research.

The growing amount of data in operational electronic health record systems provides unprecedented opportunity for its reuse for many tasks, including comparative effectiveness research. However, there are many caveats to the use of such data. Electronic health record data from clinical settings may be inaccurate, incomplete, transformed in ways that undermine their meaning, unrecoverable for research, of unknown provenance, of insufficient granularity, and incompatible with research protocols. However, the quantity and real-world nature of these data provide impetus for their use, and we develop a list of caveats to inform would-be users of such data as well as provide an informatics roadmap that aims to insure this opportunity to augment comparative effectiveness research can be best leveraged.

Applicability Area: A novel utility-based approach for evaluating predictive models, beyond discrimination.

Translating prediction models into practice and supporting clinicians' decision-making demand demonstration of clinical value. Existing approaches to evaluating machine learning models emphasize discriminatory power, which is only a part of the medical decision problem. We propose the Applicability Area (ApAr), a decision-analytic utility-based approach to evaluating predictive models that communicate the range of prior probability and test cutoffs for which the model has positive utility; larger ApArs suggest a broader potential use of the model. We assess ApAr with simulated datasets and with three published medical datasets. ApAr adds value beyond the typical area under the receiver operating characteristic curve (AUROC) metric analysis. As an example, in the diabetes dataset, the top model by ApAr was ranked as the 23rd best model by AUROC. Decision makers looking to adopt and implement models can leverage ApArs to assess if the local range of priors and utilities is within the respective ApArs.

Effectiveness of artificial intelligence screening in preventing vision loss from diabetes: a policy model.

The effectiveness of using artificial intelligence (AI) systems to perform diabetic retinal exams ('screening') on preventing vision loss is not known. We designed the Care Process for Preventing Vision Loss from Diabetes (CAREVL), as a Markov model to compare the effectiveness of point-of-care autonomous AI-based screening with in-office clinical exam by an eye care provider (ECP), on preventing vision loss among patients with diabetes. The estimated incidence of vision loss at 5 years was 1535 per 100,000 in the AI-screened group compared to 1625 per 100,000 in the ECP group, leading to a modelled risk difference of 90 per 100,000. The base-case CAREVL model estimated that an autonomous AI-based screening strategy would result in 27,000 fewer Americans with vision loss at 5 years compared with ECP. Vision loss at 5 years remained lower in the AI-screened group compared to the ECP group, in a wide range of parameters including optimistic estimates biased toward ECP. Real-world modifiable factors associated with processes of care could further increase its effectiveness. Of these factors, increased adherence with treatment was estimated to have the greatest impact.

Healthcare utilization is a collider: an introduction to collider bias in EHR data reuse.

OBJECTIVES: Collider bias is a common threat to internal validity in clinical research but is rarely mentioned in informatics education or literature. Conditioning on a collider, which is a variable that is the shared causal descendant of an exposure and outcome, may result in spurious associations between the exposure and outcome. Our objective is to introduce readers to collider bias and its corollaries in the retrospective analysis of electronic health record (EHR) data. TARGET AUDIENCE: Collider bias is likely to arise in the reuse of EHR data, due to data-generating mechanisms and the nature of healthcare access and utilization in the United States. Therefore, this tutorial is aimed at informaticians and other EHR data consumers without a background in epidemiological methods or causal inference. SCOPE: We focus specifically on problems that may arise from conditioning on forms of healthcare utilization, a common collider that is an implicit selection criterion when one reuses EHR data. Directed acyclic graphs (DAGs) are introduced as a tool for identifying potential sources of bias during study design and planning. References for additional resources on causal inference and DAG construction are provided.

Strengths, weaknesses, opportunities, and threats for the nation's public health information systems infrastructure: synthesis of discussions from the 2022 ACMI Symposium.

OBJECTIVE: The annual American College of Medical Informatics (ACMI) symposium focused discussion on the national public health information systems (PHIS) infrastructure to support public health goals. The objective of this article is to present the strengths, weaknesses, threats, and opportunities (SWOT) identified by public health and informatics leaders in attendance. MATERIALS AND METHODS: The Symposium provided a venue for experts in biomedical informatics and public health to brainstorm, identify, and discuss top PHIS challenges. Two conceptual frameworks, SWOT and the Informatics Stack, guided discussion and were used to organize factors and themes identified through a qualitative approach. RESULTS: A total of 57 unique factors related to the current PHIS were identified, including 9 strengths, 22 weaknesses, 14 opportunities, and 14 threats, which were consolidated into 22 themes according to the Stack. Most themes (68%) clustered at the top of the Stack. Three overarching opportunities were especially prominent: (1) addressing the needs for sustainable funding, (2) leveraging existing infrastructure and processes for information exchange and system development that meets public health goals, and (3) preparing the public health workforce to benefit from available resources. DISCUSSION: The PHIS is unarguably overdue for a strategically designed, technology-enabled, information infrastructure for delivering day-to-day essential public health services and to respond effectively to public health emergencies. CONCLUSION: Most of the themes identified concerned context, people, and processes rather than technical elements. We recommend that public health leadership consider the possible actions and leverage informatics expertise as we collectively prepare for the future.

Advancing Toward a Common Data Model in Ophthalmology: Gap Analysis of General Eye Examination Concepts to Standard Observational Medical Outcomes Partnership (OMOP) Concepts.

Purpose: Evaluate the degree of concept coverage of the general eye examination in one widely used electronic health record (EHR) system using the Observational Health Data Sciences and Informatics Observational Medical Outcomes Partnership (OMOP) common data model (CDM). Design: Study of data elements. Participants: Not applicable. Methods: Data elements (field names and predefined entry values) from the general eye examination in the Epic foundation system were mapped to OMOP concepts and analyzed. Each mapping was given a Health Level 7 equivalence designation-equal when the OMOP concept had the same meaning as the source EHR concept, wider when it was missing information, narrower when it was overly specific, and unmatched when there was no match. Initial mappings were reviewed by 2 graders. Intergrader agreement for equivalence designation was calculated using Cohen's kappa. Agreement on the mapped OMOP concept was calculated as a percentage of total mappable concepts. Discrepancies were discussed and a final consensus created. Quantitative analysis was performed on wider and unmatched concepts. Main Outcome Measures: Gaps in OMOP concept coverage of EHR elements and intergrader agreement of mapped OMOP concepts. Results: A total of 698 data elements (210 fields, 488 values) from the EHR were analyzed. The intergrader kappa on the equivalence designation was 0.88 (standard error 0.03, P < 0.001). There was a 96% agreement on the mapped OMOP concept. In the final consensus mapping, 25% (1% fields, 31% values) of the EHR to OMOP concept mappings were considered equal, 50% (27% fields, 60% values) wider, 4% (8% fields, 2% values) narrower, and 21% (52% fields, 8% values) unmatched. Of the wider mapped elements, 46% were missing the laterality specification, 24% had other missing attributes, and 30% had both issues. Wider and unmatched EHR elements could be found in all areas of the general eye examination. Conclusions: Most data elements in the general eye examination could not be represented precisely using the OMOP CDM. Our work suggests multiple ways to improve the incorporation of important ophthalmology concepts in OMOP, including adding laterality to existing concepts. There exists a strong need to improve the coverage of ophthalmic concepts in source vocabularies so that the OMOP CDM can better accommodate vision research. Financial Disclosures: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Human-Centered Design of a Clinical Decision Support for Anemia Screening in Children with Inflammatory Bowel Disease.

BACKGROUND: Inflammatory bowel disease (IBD) commonly leads to iron deficiency anemia (IDA). Rates of screening and treatment of IDA are often low. A clinical decision support system (CDSS) embedded in an electronic health record could improve adherence to evidence-based care. Rates of CDSS adoption are often low due to poor usability and fit with work processes. One solution is to use human-centered design (HCD), which designs CDSS based on identified user needs and context of use and evaluates prototypes for usefulness and usability. OBJECTIVES: this study aimed to use HCD to design a CDSS tool called the IBD Anemia Diagnosis Tool, IADx. METHODS: Interviews with IBD practitioners informed creation of a process map of anemia care that was used by an interdisciplinary team that used HCD principles to create a prototype CDSS. The prototype was iteratively tested with "Think Aloud" usability evaluation with clinicians as well as semi-structured interviews, a survey, and observations. Feedback was coded and informed redesign. RESULTS: Process mapping showed that IADx should function at in-person encounters and asynchronous laboratory review. Clinicians desired full automation of clinical information acquisition such as laboratory trends and analysis such as calculation of iron deficit, less automation of clinical decision selection such as laboratory ordering, and no automation of action implementation such as signing medication orders. Providers preferred an interruptive alert over a noninterruptive reminder. CONCLUSION: Providers preferred an interruptive alert, perhaps due to the low likelihood of noticing a noninterruptive advisory. High levels of desire for automation of information acquisition and analysis with less automation of decision selection and action may be generalizable to other CDSSs designed for chronic disease management. This underlines the ways in which CDSSs have the potential to augment rather than replace provider cognitive work.

Associations between sleep health and obesity and weight change in adults: The Daily24 Multisite Cohort Study.

OBJECTIVES: To examine cross-sectional and longitudinal associations of individual sleep domains and multidimensional sleep health with current overweight or obesity and 5-year weight change in adults. METHODS: We estimated sleep regularity, quality, timing, onset latency, sleep interruptions, duration, and napping using validated questionnaires. We calculated multidimensional sleep health using a composite score (total number of "good" sleep health indicators) and sleep phenotypes derived from latent class analysis. Logistic regression was used to examine associations between sleep and overweight or obesity. Multinomial regression was used to examine associations between sleep and weight change (gain, loss, or maintenance) over a median of 1.66 years. RESULTS: The sample included 1016 participants with a median age of 52 (IQR = 37-65), who primarily identified as female (78%), White (79%), and college-educated (74%). We identified 3 phenotypes: good, moderate, and poor sleep. More regularity of sleep, sleep quality, and shorter sleep onset latency were associated with 37%, 38%, and 45% lower odds of overweight or obesity, respectively. The addition of each good sleep health dimension was associated with 16% lower adjusted odds of having overweight or obesity. The adjusted odds of overweight or obesity were similar between sleep phenotypes. Sleep, individual or multidimensional sleep health, was not associated with weight change. CONCLUSIONS: Multidimensional sleep health showed cross-sectional, but not longitudinal, associations with overweight or obesity. Future research should advance our understanding of how to assess multidimensional sleep health to understand the relationship between all aspects of sleep health and weight over time.

Active surveillance versus surgery for low risk prostate cancer: a clinical decision analysis.

PURPOSE: We assessed the effect of age, health status and patient preferences on outcomes of surgery vs active surveillance for low risk prostate cancer. MATERIALS AND METHODS: We used Monte Carlo simulation of Markov models of the life courses of 200,000 men diagnosed with low risk prostate cancer and treated with surveillance or radical prostatectomy to calculate quality adjusted life expectancy, life expectancy, prostate cancer specific mortality and years of treatment side effects, with model parameters derived from the literature. We simulated outcomes for men 50 to 75 years old with poor, average or excellent health status (50%, 100% and 150% of average life expectancy, respectively). Sensitivity of outcomes to uncertainties in model parameters was tested. RESULTS: For 65-year-old men in average health, surgery resulted in 0.3 additional years of life expectancy, 1.6 additional years of impotence or incontinence and a 4.9% decrease in prostate cancer specific mortality compared to surveillance, for a net difference of 0.05 fewer quality adjusted life years. Increased age and poorer baseline health status favored surveillance. With greater than 95% probability, surveillance resulted in net benefits compared to surgery for age older than 74, 67 and 54 years for men in excellent, average and poor health, respectively. Patient preferences toward life under surveillance, biochemical recurrence of disease, treatment side effects and future discount rate affected optimal management choice. CONCLUSIONS: Older men and men in poor health are likely to have better quality adjusted life expectancy with active surveillance. However, specific individual preferences impact optimal choices and should be a primary consideration in shared decision making.

Community-based, interdisciplinary geriatric care team satisfaction with an electronic health record: a multimethod study.

This multimethod study measured the impact of an electronic health record (EHR) on clinician satisfaction with clinical process. Subjects were 39 clinicians at a Program of All-inclusive Care for Elders (PACE) site in Philadelphia utilizing an EHR. Methods included the evidence-based evaluation framework, Health Information Technology Research-Based Evaluation Framework, which guided assessment of clinician satisfaction with surveys, observations, follow-up interviews, and actual EHR use at two points in time. Mixed-methods analysis of findings provided context for interpretation and improved validity. The study found that clinicians were satisfied with the EHR; however, satisfaction declined between time periods. Use of EHR was universal and wide and was differentiated by clinical role. Between time periods, EHR use increased in volume, with increased timeliness and decreased efficiency. As the first EHR evaluation at a PACE site from the perspective of clinicians who use the system, this study provides insights into EHR use in the care of older people in community-based healthcare settings.

Night eating, weight, and health behaviors in adults participating in the Daily24 study.

BACKGROUND: Night eating syndrome (NES) is associated with adverse health outcomes. This study evaluated the relationship between night eating severity, weight, and health behaviors. METHODS: Participants (N = 1017; 77.6% female, mean Body Mass Index (BMI) = 30.5, SD = 7.8 kg/m2, age = 51.1, SD = 15.0 years) were recruited from three health systems. Participants completed the Night Eating Questionnaire (NEQ) and questionnaires assessing sleep, chronotype, physical activity, diet, weight, and napping. RESULTS: In the overall sample, higher NEQ scores were associated with higher BMI (p < .001) and consumption of sugar-sweetened beverages (p < .001), as well as lower fruit/vegetable consumption (p = .001). Higher NEQ scores were associated with increased odds of having overweight/obesity (p < .001), eating fast food (p < .001), moderate-vigorous physical activity (p = .005), and smoking (p = .004). Participants who exceeded the screening threshold for NES (n = 48, 4.7%) reported elevated BMI (p = .014), an increased likelihood of overweight/obesity (p = .004), greater sugar-sweetened beverages consumption (p < .001), napping less than twice per week (p = .029), shorter sleep duration (p = .012), and a later chronotype (M = 4:55, SD = 2:45). CONCLUSION: Night eating severity was associated with obesity and intake of fast food and sugar-sweetened beverages. Interventions to address night eating and associated behaviors may enhance the efficacy of weight management interventions and promote engagement in positive health behaviors.

Harmonizing units and values of quantitative data elements in a very large nationally pooled electronic health record (EHR) dataset.

OBJECTIVE: The goals of this study were to harmonize data from electronic health records (EHRs) into common units, and impute units that were missing. MATERIALS AND METHODS: The National COVID Cohort Collaborative (N3C) table of laboratory measurement data-over 3.1 billion patient records and over 19 000 unique measurement concepts in the Observational Medical Outcomes Partnership (OMOP) common-data-model format from 55 data partners. We grouped ontologically similar OMOP concepts together for 52 variables relevant to COVID-19 research, and developed a unit-harmonization pipeline comprised of (1) selecting a canonical unit for each measurement variable, (2) arriving at a formula for conversion, (3) obtaining clinical review of each formula, (4) applying the formula to convert data values in each unit into the target canonical unit, and (5) removing any harmonized value that fell outside of accepted value ranges for the variable. For data with missing units for all the results within a lab test for a data partner, we compared values with pooled values of all data partners, using the Kolmogorov-Smirnov test. RESULTS: Of the concepts without missing values, we harmonized 88.1% of the values, and imputed units for 78.2% of records where units were absent (41% of contributors' records lacked units). DISCUSSION: The harmonization and inference methods developed herein can serve as a resource for initiatives aiming to extract insight from heterogeneous EHR collections. Unique properties of centralized data are harnessed to enable unit inference. CONCLUSION: The pipeline we developed for the pooled N3C data enables use of measurements that would otherwise be unavailable for analysis.